TriangleNCT03582033 · OUTCOME
OS: Part C
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- From date of start of study treatment until date of death or censoring date (maximum up to 37 months)
What was measured
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
Analysis population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Groups in this outcome
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
| Group | Source count |
|---|---|
| Part C: SEA-BCMA 1600mg and Dexamethasone | 12 |
| Part C: SEA-BCMA 800mg and Dexamethasone | 6 |
| Part C: SEA-BCMA 1600 mg and Dexamethasone | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part C: SEA-BCMA 1600mg and Dexamethasone | 18.0 | Not reported | 1.9 | 36.4 | Not reported |
| Part C: SEA-BCMA 800mg and Dexamethasone | NA | Not reported | 3.7 | 26.0 | Median could not be calculated due to insufficient number of participants with events. |
| Part C: SEA-BCMA 1600 mg and Dexamethasone | 12.2 | Not reported | 1.2 | 22.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 36.4
- value
- 18.0
- comment
- Median could not be calculated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 26.0
- value
- NA
- group Id
- OG002
- lower Limit
- 1.2
- upper Limit
- 22.2
- value
- 12.2
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
- dispersion Type
- Full Range
- groups
- description
- Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG000
- title
- Part C: SEA-BCMA 1600mg and Dexamethasone
- description
- Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG001
- title
- Part C: SEA-BCMA 800mg and Dexamethasone
- description
- Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
- id
- OG002
- title
- Part C: SEA-BCMA 1600 mg and Dexamethasone
- param Type
- MEDIAN
- population Description
- All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
- reporting Status
- POSTED
- time Frame
- From date of start of study treatment until date of death or censoring date (maximum up to 37 months)
- title
- OS: Part C
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice